Definition of wearable devices

• Devices for personal use such as rings, watches and wristbands which offer continuous or repeated automatic BP measurement measured by means other than a pneumatic cuff

• We do not include ambulatory blood pressure monitors; these use existing technology, can be validated using existing international protocols, and may be considered as professional devices

• Similarly, some personal cuff-based devices, such as watches, may be worn but we exclude these for the same reasons

 

Blood Pressure Wearables - Holding Position

The British & Irish Hypertension Society (BIHS) is aware of the rapid growth in blood pressure “wearables” and digital monitoring devices. At present, BIHS does not have a formal validation process for wearable devices. Our current validation and endorsement processes apply only to conventional arm- and wrist-cuff blood pressure monitors.

However, we recognise the potential of wearable technology and AI-driven solutions to transform blood pressure detection, monitoring, and self-management.

For this reason:

• BIHS is actively developing a framework for assessing wearables, building on international standards and our long-standing role in validating conventional devices.

• In late 2025, BIHS will convene a high-level stakeholder engagement event with regulators, policymakers, NHS leaders, academic experts, and industry representatives to define standards and expectations for wearable blood pressure monitoring.

• This process will inform the creation of formal review pathways for wearables and digital technologies, ensuring that future recommendations are robust, transparent, and in line with BIHS’s mission to protect patients and support clinical best practice.

• Until these processes are in place, BIHS cannot endorse or approve any wearable blood pressure devices. Patients, clinicians, and organisations are advised to continue using devices listed on the BIHS validated monitor list  which remains the gold standard for accuracy and reliability.

BIHS statement on Derivative Devices 2022

Devices that are listed as being derivative of other models have been approved for addition to these lists on the basis of information supplied to the BIHS by the manufacturer. This comprises a checklist of the key components of each monitor (including algorithm, pressure sensors, inflation/deflation processes) which the manufacturer attests have not been materially changed from the originally validated device. This information has been carefully reviewed, but manufacturers’ attestations are accepted in good faith.

From 1^st April 2023, the BIHS will only accept new derivative device applications where the original device validation was carried out under the European Society of Hypertension International Protocol revision 2010[1] or the Universal Standard (AAMI/ESH/ISO) validation protocol 2018. [2][3] This is because by that stage the 2002 ESH International Protocol is now considered obsolete.

From 1^st April 2025, the BIHS will only accept new derivative device applications where the original device validation was carried out under the 2018 Universal Standard (AAMI/ESH/ISO) protocol or a subsequent modification of that protocol.

 

The new portal for validation applications is coming soon.